Devices and Methods for Percutaneous Tricuspid Valve Repair

ABSTRACT

The present teachings provide devices and methods of treating a tricuspid valve regurgitation. Specifically, one aspect of the present teachings provides devices and methods of identifying a suitable location on the tricuspid annulus, another aspect of the present teachings provides devices and methods of placing a wire across the tricuspid annulus at such an identified location, another aspect of the present teachings provides devices and methods of deploying a tissue anchor across such an identified location, and yet another aspect of the present teachings provides devices and methods of applying tension to two or more of such tissue anchors and reducing the circumference of the tricuspid annulus. As a result, a regurgitation jet is reduced or eliminated.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. patent application Ser. No.61/769,738, filed Feb. 26, 2013, which is hereby incorporated byreference in its entirety.

TECHNICAL FIELD

The present teachings generally relate to percutaneous valve repair.Some embodiments of the present teachings relate to percutaneoustricuspid valve repair.

BACKGROUND

Tricuspid valve diseases relate to conditions in which the valve betweenthe two right heart chambers (i.e., the right ventricle and the rightatrium) doesn't function properly and they often occur with other heartvalve problems. An example of tricuspid valve diseases is tricuspidvalve regurgitation, where the tricuspid valve doesn't close properlyand blood flows back into the right atrium. Another example is tricuspidvalve stenosis where the tricuspid valve is narrowed, which reduces theamount of blood flowing into the right ventricle. Yet another example istricuspid atresia, a congenital heart disease, where a solid wall oftissues blocks the blood from flowing between the two right heartchambers. Yet another example is the Ebstein's anomaly where a malformedtricuspid valve situates at a position lower than the normal in theright ventricle, causing blood to flow back into the right atrium. Thereare other tricuspid valve diseases generally known to a person withordinary skill in the art and these tricuspid valve diseases are alsoincluded in the present teachings.

A tricuspid valve disease can be corrected by an annuloplasty ring. Insome instances, this device is preferred for surgically repairing adefect tricuspid valve. An annuloplasty ring is an anatomically-correctthree-dimensional (3D) ring and can flexibly conform to the heart valveopening. This ring is implanted into a defect tricuspid valve andreduces the valve opening. Properly implanted, an annuloplasty ringallows the valve to open and close properly.

Tricuspid valve repair surgery can be done in one of two ways: aminimally invasive surgery or an open-heart surgery. A minimallyinvasive method involves making a small upper or lower chest incisionand inserting valve repairing system/device percutaneously. After thevalve is repaired, the incision is closed with dissolving sutures.Advantages of a minimally invasive approach include a shorter recoverytime, less post-operation pain, and earlier return to work and normaldaily activities.

SUMMARY

One aspect of the present teachings provides a method for percutaneouslyreducing the circumference of a tricuspid annulus. This method includesa number of steps, the sequence of which can be changed and each ofwhich can be omitted or modified without the method falling outside thescope of the present teachings. An exemplary step includes positioning awire delivery catheter through the tricuspid valve into the rightventricle. Another exemplary step includes contacting a distal end ofthe wire delivery catheter with the tricuspid annulus inside the rightventricle at a first location. Another exemplary step includes advancingone end of a wire from the right ventricle across the tricuspid annulusto the right atrium at the first location, where the wire tracks throughan axial lumen of the wire delivery catheter. Another exemplary stepincludes capturing the end of the wire with a capture device deployedinside the right atrium. Another exemplary step includes retracting thecapture device proximally to bring the end of the wire outside of thebody. Another exemplary step includes tracking a first tissue anchordelivery catheter over the wire and extending the first tissue anchordelivery catheter across the tricuspid annulus so that a distal end ofthe first tissue anchor delivery catheter resides inside the rightventricle. Another exemplary step includes deploying a first tissueanchor with a distal portion of the tissue anchor positioning againstthe tricuspid annulus from inside the right ventricle and a proximalportion of the tissue anchor positioning against the tricuspid annulusfrom inside the right atrium. Another exemplary step includes retractingthe end of the wire back into the axial lumen of the wire deliverycatheter.

Another exemplary step includes positioning the wire delivery catheterwith the distal end of the wire delivery catheter contacting thetricuspid annulus inside the right ventricle at a second location.Another exemplary step includes advancing the end of the wire from theright ventricle across the tricuspid annulus to the right atrium.Another exemplary step includes capturing the end of the wire with acapture device deployed inside the right atrium. Another exemplary stepincludes retracting the capture device proximally and thereby extendingthe end of the wire outside of the body. Another exemplary step includestracking a second tissue anchor delivery catheter over the wire. Anotherexemplary step includes extending the second tissue anchor deliverycatheter across the tricuspid annulus at the second location so that adistal end of the second tissue anchor delivery catheter resides insidethe right ventricle. Another exemplary step includes deploying a secondtissue anchor with a distal portion of the tissue anchor positioningagainst the tricuspid annulus from inside the right ventricle and aproximal portion of the tissue anchor positioning against the tricuspidannulus from inside the right atrium. Another exemplary step includesreducing the distance between the first and second tissue anchors.

In other embodiments, a method for percutaneously reducing thecircumference of a tricuspid annulus includes a number of other steps,the sequence of which can be changed and each of which can be omitted ormodified without the method falling outside the scope of the presentteachings. An exemplary step includes positioning a locating catheterthrough the tricuspid valve into the right ventricle. Another exemplarystep includes contacting a distal end of the locating catheter with thetricuspid annulus inside the right ventricle at a first location.Another exemplary step includes advancing a wire delivery catheter intothe right atrium with a distal end of the wire delivery catheteropposing the distal end of the locating catheter and contacting thetricuspid annulus inside the right atrium at the first location. Anotherexemplary step includes advancing a distal end of a wire from the rightatrium across the tricuspid annulus to the right ventricle at the firstlocation, wherein the wire tracks through an axial lumen of the wiredelivery catheter. Another exemplary step includes tracking a firsttissue anchor delivery catheter over the wire. Another exemplary stepincludes crossing the tricuspid annulus with a distal end of the firsttissue anchor delivery catheter inside the right ventricle. Anotherexemplary step includes deploying a first tissue anchor with a distalportion of the tissue anchor positioning against the tricuspid annulusfrom inside the right ventricle and a proximal portion of the tissueanchor positioning against the tricuspid annulus from inside the rightatrium. Another exemplary step includes retracting the distal end of thewire back into the axial lumen of the wire delivery catheter. Anotherexemplary step includes positioning the locating catheter with thedistal end of the locating catheter contacting the tricuspid annulusinside the right ventricle at a second location. Another exemplary stepincludes positioning the wire delivery catheter into the right atriumwith the distal end of the wire delivery catheter opposite to the distalend of the locating catheter and contacting the tricuspid annulus insidethe right atrium at the second location. Another exemplary step includesadvancing the distal end of the wire from the right atrium across thetricuspid annulus to the right ventricle. Another exemplary stepincludes tracking a second tissue anchor delivery catheter over the wireand crossing the tricuspid annulus at the second location with a distalend of the second tissue anchor delivery catheter inside the rightventricle. Another exemplary step includes deploying a second tissueanchor with a distal portion of the tissue anchor positioning againstthe tricuspid annulus from inside the right ventricle and a proximalportion of the tissue anchor positioned against the tricuspid annulusfrom inside the right atrium. Another exemplary step includes reducingthe distance between the first and second tissue anchors.

In other embodiments, a method for percutaneously reducing thecircumference of a tricuspid annulus includes a number of steps, thesequence of which can be changed and each of which can be omitted ormodified without the method falling outside the scope of the presentteachings. An exemplary step includes positioning a wire deliverycatheter through the tricuspid valve into the right ventricle, wherein amulti-lumen translation catheter is slidably disposed within a lumen ofthe wire delivery catheter, a first wire is slidably disposed within afirst catheter member of the multi-lumen translation catheter, a secondwire is slidably disposed within a second catheter member of themulti-lumen translation catheter. Another exemplary step includespositioning a distal end of the first catheter member at a firstlocation. Another exemplary step includes advancing one end of the firstwire from the right ventricle across the tricuspid annulus to the rightatrium at the first location. Another exemplary step includes expandingthe second catheter member of the multilumen translation catheter.Another exemplary step includes positioning a distal end of the secondcatheter member against the tricuspid annulus at a second location.Another exemplary step includes advancing one end of the second wirefrom the right ventricle across the tricuspid annulus to the rightatrium at the second location. Another exemplary step includes capturingthe ends of the first and second wires with a capture device. Anotherexemplary step includes retracting the capture device proximally andextending the ends of the first and second wires outside of the body.Another exemplary step includes tracking a first tissue anchor deliverycatheter over the first wire and a second tissue anchor deliverycatheter over the second wire. Another exemplary step includes crossingthe tricuspid annulus with distal ends of the first and second tissueanchor delivery catheters inside the right ventricle. Another exemplarystep includes deploying the first and second tissue anchors with distalportions of the first and second tissue anchors positioning against thetricuspid annulus from inside the right ventricle and proximal portionsof the first and second tissue anchors positioning against the tricuspidannulus from inside the right atrium. Another exemplary step includesreducing the distance between the first and second tissue anchors.

In other embodiments, a method for percutaneously reducing thecircumference of a tricuspid annulus includes a number of steps, thesequence of which can be changed and each of which can be omitted ormodified without the method falling outside of the present teachings. Anexemplary step includes positioning a locating catheter through thetricuspid valve into the right ventricle, wherein a multi-lumentranslation catheter is slidably disposed within a lumen of the locatingcatheter and the multi-lumen translation catheter has a first cathetermember and a second catheter member. Another exemplary step includespositioning a distal end of the first catheter member at a firstlocation. Another exemplary step includes expanding the second cathetermember of the multi-lumen translation catheter and positioning a distalend of the second catheter member against the tricuspid annulus at asecond location. Another exemplary step includes advancing first andsecond wire delivery catheters into the right atrium with distal ends ofthe first and second wire delivery catheters positioned opposite to thedistal ends of the first and second catheter member. Another exemplarystep includes contacting the tricuspid annulus inside the right atriumat the first and second locations. Another exemplary step includesadvancing distal ends of first and second wires from the right atriumacross the tricuspid annulus to the right ventricle at the first andsecond locations. Another exemplary step includes tracking the first andsecond tissue anchor delivery catheters over the first and second wiresand crossing the tricuspid annulus with distal ends of the first andsecond tissue anchor delivery catheters inside the right ventricle.Another exemplary step includes deploying the first and second tissueanchors with distal portions of the first and second tissue anchorspositioned against the tricuspid annulus from inside the right ventricleand proximal portions of the first and second tissue anchors positionedagainst the tricuspid annulus from inside the right atrium. Anotherexemplary step includes reducing the distance between the first andsecond tissue anchors.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary guide percutaneouslyinserted into the right atrium in accordance with the present teachings;

FIGS. 2 a-2 b are perspective views of an exemplary wire deliverycatheter inserted into the right ventricle in accordance with thepresent teachings;

FIGS. 3 a-3 b are perspective views of an exemplary capture devicedeployed inside the right atrium in accordance with the presentteachings;

FIGS. 4 a-4 b are perspective views of an exemplary wire positionedacross the annulus in accordance with the present teachings;

FIG. 5 is a perspective view of an exemplary wire captured and pulledthrough the guide in accordance with the present teachings;

FIG. 6 is a perspective view of an exemplary wire positioned across theannulus in accordance with the present teachings;

FIGS. 7 a-7 b are perspective views of an exemplary locating catheterinserted into the right ventricle in accordance with the presentteachings;

FIGS. 7 c-7 d are perspective views of an exemplary wire across theannulus in accordance with the present teachings;

FIGS. 8 a-8 b are perspective views of an exemplary locating deviceinserted into the right ventricle in accordance with the presentteachings;

FIG. 9 is a perspective view of an exemplary wire positioned across theannulus in accordance with the present teachings;

FIG. 10 is a perspective view of an exemplary tissue anchor inaccordance with the present teachings;

FIGS. 11 a-11 c are perspective views of an exemplary tissue anchordeployed across the tricuspid annulus in accordance with the presentteachings;

FIGS. 12 a-12 c are perspective views of an exemplary tissue anchordeployed across the tricuspid annulus in accordance with the presentteachings;

FIGS. 13 a-13 b are perspective views of an exemplary method where anexemplary second wire extends across the tricuspid annulus in accordancewith the present teachings;

FIGS. 14 a-14 b are perspective views of an exemplary second tissueanchor deployed across the tricuspid annulus in accordance with thepresent teachings;

FIG. 15 is a perspective view of applying tension to two exemplarytissue anchors deployed across annulus in accordance with the presentteachings;

FIGS. 16 a-16 f are perspective views of an example of applying tensionto multiple exemplary tissue anchors deployed across the tricuspidannulus in accordance with the present teachings;

FIG. 17 is a perspective view of an exemplary multi-lumen translationcatheter in accordance with the present teachings;

FIGS. 18 a-18 b are perspective views of an example of placing twoexemplary wires across the tricuspid annulus with an exemplarymulti-lumen translation catheter in accordance with the presentteachings;

FIGS. 19 a-19 b are perspective views of an example of placing twoexemplary wires across the tricuspid annulus with an exemplarymulti-lumen translation catheter in accordance with the presentteachings;

FIGS. 20 a-20 c are perspective views of placing multiple tissue anchorsacross the tricuspid annulus in accordance with the present teachings;and

FIGS. 21 a-21 c are perspective views of placing multiple tissue anchorsacross the tricuspid annulus in accordance with the present teachings.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

Certain specific details are set forth in the following description andfigures to provide an understanding of various embodiments of thepresent teachings. Those of ordinary skill in the relevant art wouldunderstand that they can practice other embodiments of the presentteachings without one or more of the details described herein. Thus, itis not the intention of the Applicant(s) to restrict or in any way limitthe scope of the appended claims to such details. While variousprocesses are described with reference to steps and sequences in thefollowing disclosure, the steps and sequences of steps should not betaken as required to practice all embodiments of the present teachings.

As used herein, the term “lumen” means a canal, a duct, or a generallytubular space or cavity in the body of a subject, including a catheter,a hollow needle, a tube, a vein, an artery, a blood vessel, a capillary,an intestine, and the like.

As used herein, the term “proximal” shall mean close to the operator(less into the body) and “distal” shall mean away from the operator(further into the body). In positioning a medical device inside apatient, “distal” refers to the direction away from a catheter insertionlocation and “proximal” refers to the direction close to the insertionlocation.

As used herein, the term “wire” can be a strand, a cord, a fiber, ayarn, a filament, a cable, a thread, or the like, and these terms may beused interchangeably.

As used herein, the term “sheath” may also be described as a “catheter”and, thus, these terms can be used interchangeably.

The following description refers to FIGS. 1 to 19. A person withordinary skill in the art would recognize that the figures anddescription thereto refer to various embodiments of the presentteachings and, unless indicated otherwise by their contexts, do notlimit the scope of the attached claims to the figures and/or descriptionthereto.

Unless otherwise specified, all numbers expressing quantities,measurements, and other properties or parameters used in thespecification and claims are to be understood as being modified in allinstances by the term “about.” Accordingly, unless otherwise indicated,it should be understood that the numerical parameters set forth in thefollowing specification and attached claims are approximations. At thevery least and not as an attempt to limit the application of thedoctrine of equivalents to the scope of the attached claims, numericalparameters should be read in light of the number of reported significantdigits and the application of ordinary rounding techniques.

The present teachings relate to devices and methods for treating atricuspid regurgitation. An aspect of the present teachings providesvarious embodiments of locating a first location on the tricuspidannulus (3) (as shown in FIGS. 1 to 19). According to some embodiments,the first location is on the posterior annulus approximate to thecommissure of the posterior and septal leaflets or to the commissure ofthe posterior and anterior leaflets.

A further aspect of the present teachings provides various embodimentsof placing a wire across the tricuspid annulus (3) at the firstlocation. According to some embodiments, the wire crosses the tricuspidannulus (3) from the right atrium to the right ventricle (4) (as shownin FIGS. 1 to 19). According to some embodiments, a wire of the presentteachings crosses the tricuspid annulus (3) from the right ventricle tothe right atrium (8) (as shown in FIGS. 1 to 19). A further aspect ofthe present teachings provides various embodiments of deploying a tissueanchor (310 a) (as shown, for example, in FIG. 11 a) over the wire andacross the tricuspid annulus. According to some embodiments, the distalportion of the tissue anchor (310 a) is deployed inside the rightventricle (4) and the proximal portion of the tissue anchor (310 a) isdeployed inside the right atrium (8). According to some embodiments, thedistal portion of the tissue anchor (310 a) is deployed inside the rightatrium (8) and the proximal portion of the tissue anchor (310 a) isdeployed inside the right ventricle (4).

A further aspect of the present teachings provides various embodimentsof locating a second location (30) (as shown, for example, in FIG. 13 a)on the tricuspid annulus (3), placing a second wire across the tricuspidannulus (3), and then deploying a second tissue anchor (310) (as shown,for example, in FIG. 14 a) across the tricuspid annulus.

A further aspect of the present teachings provides various embodimentsof reducing the circumference of the tricuspid annulus (3). An exemplarymethod of the present teachings begins by percutaneously accessing thetricuspid annulus (3) from a suitable venous access site. According tosome embodiments, the venous access site is located near the jugularvein, superiorly, from the femoral vein, inferiorly, or from othersuitable sites. According to some embodiments of the present teachings,as illustrated in FIG. 1, a suitable guide (12) is directed into theinternal jugular vein, extends through the right brachiocephalic vein,the superior vena cava (6), and reaches the right atrium (8). The distalend (10) of the guide (12) remains inside the right atrium (8). Theproximal end (not shown) of the guide (12) remains outside of the body.According to some embodiments, the guide (12) could have a generalstraight profile. In another embodiment, the guide (12) could have acurved distal portion. In some embodiments, the distal portion of theguide (12) could have a pre-set fixed curved. In another embodiment, thedistal portion of the guide (12) could be deflectable curved sectioncontrolled by a clinician from outside of the body. The guide (12) hasan axial lumen (14) extending from its proximal end through its entirelength to its distal end (10). This axial lumen (14) of the guide (2)serves as a conduit, allowing one or more catheters to be slidablydisposed within and providing access to the right heart chambers.According to some embodiments, the guide (12) remains in place asillustrated in FIG. 1 during the entire procedure. According to someembodiments, the guide (12) is removed, for example, during theprocedure when other suitable means, such as a wire, maintains such apercutaneous access. According to some embodiments, the guide (12) is a12 French (F) sheath. According to some embodiments, the guide (12) is asingle lumen sheath that can accommodate all subsequent catheters toslide therein. Alternatively, in some embodiments, the guide (12) is amulti-lumen sheath. It will be appreciated by persons of ordinary skillin the art that the size and the exact configuration of the guide (12)is not limited to what is disclosed herein.

In various embodiments, a percutaneous repair of the tricuspid valve (2)starts with identifying and obtaining an access to a first location onthe tricuspid annulus (3). FIGS. 2-6 illustrate some embodiments where awire gains an access to the tricuspid valve (2) from the right ventricle(4) and is advanced across the tricuspid annulus (3) into the rightatrium (8). Upon doing so, the distal end of the wire extends from thevenous access site through the lumen (14) of the guide (12), reaches theright atrium (8), extends distally through the tricuspid valve (2),reaches the right ventricle (4), advances across the tricuspid valve (2)annulus, and extends proximally out of the body through the lumen (14)of the guide (12). As a result, both ends of the wire are outside of thebody.

FIG. 2 a illustrates an embodiment where a wire delivery catheter (20)is directed into the right ventricle (4). In one embodiment, a wiredelivery catheter is inserted (20) from the proximal end of the guide(12) through the lumen (14) of the guide (12) and reaches the rightatrium (8). As shown in FIG. 2 a, as the distal end (24) of the wiredelivery catheter (20) extends beyond the distal end (10) of the guide(12), the wire delivery catheter (20) is extended further distallythrough the tricuspid valve (2) and reaches the right ventricle (4).Inside the right ventricle (4), the distal end portion (22) of the wiredelivery catheter (20) bends radially away from the longitudinal axis ofthe wire delivery catheter (20), assuming a curved profile. According tosome embodiments, the curved profile of the distal end portion (22) ofthe wire delivery catheter (20) is in the shape of the letter “J,” theletter “U,” or any curvature between 90° to 270′ as marked as “θ” inFIG. 2 a. According to some embodiments, the distal end portion (22) ofthe wire delivery catheter (20) has a preformed curve, such that as thedistal end (24) of the wire delivery catheter leaves the constraint ofthe guide (12) and enters the right ventricle (4), the distal endportion (22) of the wire delivery catheter (20) resumes its curvedprofile. According to some other embodiments, the wire delivery catheter(20) has a deflectable distal end portion (22), which is actuated toform a curved profile. One skilled in the art would understand that suchan actuation can be accomplished by many mechanisms known in the field.According to some embodiments, the wire delivery catheter (20) can beextended distally, retracted proximally, or turned axially as shown bythe double-headed arrows in FIG. 2 a.

As further illustrated in FIG. 2 b, the distal end (24) of the wiredelivery catheter (20) is adapted to locate the first location (32) andthen make contact with the tricuspid annulus (3) at the right ventricle(4) side.

Anatomically, the right coronary artery is approximately parallel to thecircumference of the tricuspid valve (2). The anterior and septalleaflets lie approximately to the proximal half of the right coronaryartery. The posterior leaflet of the tricuspid lies approximately to thedistal half of the right coronary artery and between the middle of theright coronary artery and the transition of the distal right coronaryartery to the posterior descending artery. The middle of the rightcoronary artery lies approximately next to the commissure of theanterior and posterior leaflets. The transition of the distal rightcoronary artery to the posterior descending artery, or the proximalposterior descending artery, lies approximately next to the commissureof the septal and posterior leaflets. One skilled in the art wouldunderstand that the anatomy of the heart may vary from a subject toanother and the present teachings and the attached claims are notlimited to the anatomy of any particular subject.

According to some embodiments, a first location (32) is identified byinjecting a contrast dye inside the right coronary artery and the distalposterior descending artery. Alternatively, a location can be identifiedby advancing a radiopaque wire through the right coronary artery to theposterior descending artery. In various embodiments, the contrast dyeand/or the radiopaque wire renders the right coronary artery visibleunder radiographic imaging equipment such as X-ray, magnetic resonance,ultrasound, fluoroscope, or other imaging techniques. By visualizing theright coronary artery and the posterior descending artery, a locationcan be identified.

Upon identifying the first location (32), in various embodiments, aclinician steers the wire delivery catheter so that, as shown in FIG. 2b, the distal end (24) of the wire delivery catheter (20) aligns at thetricuspid annulus (3), extends toward the right atrium (8), and contactsthe tricuspid annulus (3) at the first location (32). According to oneembodiment, the first location (32) is at or near the commissure of theseptal and posterior leaflets. Alternatively, the first location (32) isat or near the commissure of the anterior and posterior leaflets. Oneskilled in the art would understand that other locations along thetricuspid annulus (3) can also be used as a first location.

In various embodiments, upon aligning the distal end (24) of the wiredelivery catheter (20) at the location (32), a capture device (40) isdeployed inside the right atrium (8). FIG. 3 a illustrates an embodimentwhere a capture device (40) is advanced distally through the guide (12)and into the right atrium (8). According to some embodiments, a capturedevice (40) includes a sheath (42) and a capture basket (44). In someembodiments, a capture devices, such as the one illustrated in FIG. 3 a,includes a capture basket (44) having an array of shape memory wire meshon the distal end (48) of a rod (46). According to some embodiments, thecapture basket (44) has a radially expanded basket-like profile forcapturing the wire as described below and an elongated profile whenbeing constrained within the sheath (42). The capture basket (42) asshown in FIG. 3 a is adapted to slide through the axial lumen (41) ofthe sheath (42), be pushed out of the distal end (43) of the sheath(42), and be retracted back from the distal end (43) of the sheath (42).As the capture basket (44) extends outside of the distal end (43) of thesheath (42), it resumes its expanded profile. As the capture basket (44)is retracted back into the sheath (42), it collapses into its elongatedprofile. One skilled in the art would understand that the capture basket(44) can be used without the sheath (42), but with the guide (12) alone.Thus what has been described herein should not be viewed as limiting.Additionally, one skilled in the art should understand that although anexemplary embodiment of the capture device has been described in detailherein, other capture device available in the art can also be used forthe same purpose to capture the wire. For example a gooseneck snaremechanism can be used. In some embodiment, the snare catheter isconstructed of Nitinol cable and with a snare loop. The preformed snareloop can be introduced through catheters without risk of snaredeformation because of the snare's super-elastic construction. The snareloop is used to capture the distal end of the wire.

In an exemplary use of the device, as illustrated in FIG. 3 a, a capturedevice (40) having a capture basket (44) constrained to its elongatedprofile within the sheath (42) is directed through the lumen (14) of theguide (12). According to some embodiments, when a multi-lumen sheath isused as the guide, the capture device (40) extends through a separatelumen from the one used by the wire delivery catheter (20). According toother embodiments, when a single-lumen sheath is used as the guide, thecapture device (40) extends side-by-side with the wire delivery catheter(20) through the same lumen of the guide. Once the distal end of thecapture device (40) is advanced beyond the distal end (10) of the guide(12) and reaches the right atrium (8), the capture basket (44) isfurther pushed distally outside of the sheath (42) and, being free fromthe constraint of the sheath (42), the capture basket (44) deploys. Thedeployed capture basket (44) can at least partially fill the volume ofthe right atrium (8). One skilled in the art should understand thatmultiple guides could also be used, one for the delivery capture device,and the other for the delivery of the wire delivery catheter. Thus theexemplary embodiment disclosure herein should be not viewed as limiting.

FIG. 3 b illustrates another embodiment of the capture device (50).According some embodiments, the capture device (50) includes a capturebasket (52) at the distal end (54) of an elongated body (56). Thecapture device (50), including the elongated body (56) and the capturebasket (52) forming an axial lumen, is slidably disposed over the wiredelivery catheter (20). Similar to the embodiment shown in FIG. 3 a,this capture basket (52) is adapted to slide through the axial lumen(14) of the guide (12). Also similar to the embodiment shown in FIG. 3a, the capture basket (52) has an elongated profile when it isconstrained within the lumen (14) of the guide (12) and a radiallyexpanded basket-like profile when it is outside of the guide (12).Similarly, the capture basket (52) can be made of an array of shapememory wire mesh.

According to some embodiments, this capture device (50) is adapted toslide over the wire delivery catheter (20), through the lumen (14) ofthe guide (12), and be pushed out of the distal end (10) of the guide(12). As the capture device (50) extends outside of the distal end (10)of the guide (12), it resumes its expanded profile. As the capturedevice (50) is retracted into the lumen (14) of the guide (12), itcollapses into its elongated profile. According to some embodiments, themovement of the capture device (50) is independent of the movement ofthe wire delivery catheter (20). According to other embodiments, themovement of the capture device (50) is dependent to the movement of thewire delivery catheter (20) such that. In certain embodiments, as thedistal end (24) of the wire delivery catheter (20) contacts the annulus(3), the capture basket (52) is extended outside of the guide (12) andfully deployed inside the right atrium (8). Although certain embodimentsof the capture basket (52) are shown in FIGS. 3 a and 3 b, one skilledin the art would understand that other capture devices can also be usedwithout departing from the spirit of the present teachings. Thus, whatis disclosed in present teachings should not be viewed as limiting.

Besides having a capture basket, according to another embodiment, acapture device includes a sheath with an expandable distal portion or asnare. One skilled in the art would understand that other types ofsuitable capture devices can also be used here. Thus what is disclosedherein and in FIGS. 3 a-3 b should not be considered as limiting.

In various embodiments, with the capture basket deployed inside theright atrium (8) and the wire delivery catheter (20) properlypositioned, a clinician can extend a wire (60 a) across the tricuspidannulus (3). Referring to FIG. 4 a, a wire is introduced through thewire delivery catheter (20). In the embodiment as illustrated in FIG. 4a, the wire (60 a) tracks through the axial lumen (26) of the deliverycatheter (20), extends distally from its proximal end, contacts thetricuspid annulus (3), further extends distally, crosses the annulus (3)from the right ventricle (4) side, enters into the right atrium (8), andenters the space filled by the capture basket (44, 52). In someembodiments, the wire is captured by the capture basket.

According to some embodiments, as illustrated in FIG. 4 a, the wire (60a) has a piercing tip which allows it to perforate the annulus (3).According to other embodiments, the wire (60 a) has a radio frequency(RF) energy delivery tip to assist its crossing of the tricuspid annulus(3). In these other embodiments, a suitable RF energy device (not shown)is coupled to the wire.

Yet according to other embodiments, as illustrated in FIG. 4 b, the wiredelivery catheter (20) also includes an extendable needle (28) that iscapable of piercing the tricuspid annulus (3). The wire (60 a) tracksthrough the lumen (26) of the such wire delivery catheter (20), extendsthrough the aperture created by the extendable needle (28) of thecatheter (20), reaches into the right atrium (8), and enters into thespace filled by the capture basket (44, 52). In some embodiments, thewire is captured by the capture basket (44, 52). One skilled in the artwould understand that other methods and devices can also be used toaccess the right atrium (8). Thus, the particular examples describedherein should be not viewed as limiting to the scope of the presentteachings.

According to some embodiments, the distal portion of the wire (60 a) isdesigned to deflect or curl back to prevent inadvertent tissue damage.The ability to deflect or curl can be achieved by the geometricalconstruct of the wire (60 a), such as a flexible distal portion (62), bythe physical property of the material used in making the wire (60 a), orby the shape memory property of the material used in making the wire (60a). Those skilled in the art would be able to incorporate knowntechniques and/or material to achieve this purpose without undueexperimentation.

Now referring to FIG. 5, as the wire enters the right atrium (8) and thespace filled by the deployed capture basket (44, 52), it is captured bythe capture basket (44, 52) of the capture device (40, 50). As aclinician retracts the capture basket (44) proximally into the sheath(42) or into the guide (12), the capture basket (44, 52) collapses ontothe wire (60 a). As the clinician further retracts the capture device(40, 50) proximally, the capture device (40, 50) pulls the wire (60 a)proximally through the lumen (14) of the guide (12) and out of the body.

In various embodiments, a clinician further retracts the capture device(40), including the sheath (42) and the capture basket (55) as shown inFIG. 3 a or including the elongated member (56) with the capture basket(52) as shown in FIG. 3 b, proximally through the lumen (14) of theguide (12) outside of the body. By doing this, in some embodiments, theclinician pulls the wire (60 a) to the outside of the body. As a result,as shown in FIG. 6, with one end of the wire (60 a) remaining outside ofthe body, the other end extends from the venous access site distallythrough the lumen (26) of the wire delivery catheter (20), passes theright atrium (8), the tricuspid valve (2), and the right ventricle (4),crosses the tricuspid annulus (3) at a first location (32), extendsproximally through the lumen (14) of the guide (12), and exits thevenous access site. Thus, with both the ends outside of the body, thewire (60 a) maintains an access across the tricuspid annulus (3) at thefirst location (32) and facilitates the deployment of a tissue anchor(310 a) as detailed below.

FIGS. 7-9 illustrate some embodiments where the wire (160 a) extendsfrom the right atrium (8) across the tricuspid annulus (3) into theright ventricle (4) with the proximal end of the wire (160 a) outside ofthe body and the distal end (162) of the wire (160 a) inside the rightventricle.

FIGS. 7 a-7 c illustrate various embodiments where the wire deliverycatheter (120) is steered by a locating catheter (100) and positionedagainst the tricuspid annulus (3) inside the right atrium (8). Accordingto some embodiments, the locating catheter (100) extends distallythrough the lumen (14) of the guide (12) into the right ventricle (4).In certain embodiments, the locating catheter (100) enters into theright ventricle in a similar manner as the wire delivery catheter (20)described in accordance with FIGS. 2 a and 2 b. Following the sameidentification and placement processes as described herein, in variousembodiments, the locating catheter (100) is positioned against thetricuspid annulus (3) at the first location (32) inside the rightventricle (4). According to some embodiments, the construct of thelocating catheter (100) is similar to the wire delivery catheter (20)described above. In certain embodiments, the locating catheter has apreformed curved distal end portion (102). In certain embodiments, thelocating catheter is capable of extending distally and retractingproximally as indicated by the straight double-headed arrows in the FIG.7 a. In certain embodiments, the locating catheter is adapted to turnaxially as indicated by the curved double-headed arrows in the FIG. 7 a.

Continuing referring to FIG. 7 a, in various embodiments, the locatingcatheter (100) has a magnet (106) at its distal end (104). A wiredelivery catheter (120) is advanced distally through the lumen (14) ofthe guide (12), reaching inside the right atrium (8) and approaching thetricuspid annulus (3). According to some embodiments, the distal end(124) of the wire delivery catheter (120) includes a magnet (126). Themagnets (106, 126) on both the locating catheter (100) and the wiredelivery catheter (120) have the opposite polarities. Thus, as the wiredelivery catheter (120) approaching the tricuspid annulus (3), themagnet in the distal end of the delivery catheter is attracted by themagnet (106) on the distal end (104) of the locating catheter (100).Once the magnets (106, 126) lock up, the tricuspid annulus (3) issandwiched between the distal ends (124, 102) of the two catheters asillustrated in FIG. 7 b.

In various embodiments, a wire (160 a) is then advanced from the rightatrium (8) across the tricuspid annulus (3) into the right ventricle(4). According to some embodiments, as illustrated in FIG. 7 c, the wire(160 a) tracks along the axial lumen (122 a) of the wire deliverycatheter (120) and, upon crossing the tricuspid annulus (3), enters theaxial lumen (108) of the locating catheter (100). As the locatingcatheter (100) retracts proximally, the distal end (162) of the wire(160 a) remains inside the right ventricle (4). According to otherembodiments, as illustrated in FIG. 7 d, the wire (160 a) tracks along aside or off-centered axial lumen (122 b) of the wire delivery catheter(120) and, upon crossing the tricuspid annulus (3), the distal end (162)of the wire (160 a) enters the right ventricle (4). According to someembodiments, the wire delivery catheter (120) also has a deflectabledistal end portion (128), which allows this distal end portion (128)deflect radially when the magnet (126) at the distal end (124) of thewire delivery catheter (120) is drawn to the location (32) by the magnet(106) at the distal end (104) of the locating catheter (100), as shownin FIG. 7 b. Similarly, the wire delivery catheter (120) can be extendeddistally and retracted proximally or turned axially, as indicated by thedouble-headed arrows. According to some embodiments, the design orconfiguration of the wire (160 a) is similar to what is described hereinin according with FIGS. 4 a and 4 b.

FIGS. 8 a and 8 b illustrate yet other embodiments of the presentteachings where a wire delivery catheter (220) is guided by a locatingdevice (210). According to some embodiments, the wire delivery catheter(220) has two axial lumens (222, 224), one for a wire (260 a) and theother for a locating device (210). The wire delivery catheter (220)enters the right atrium (8) through the lumen (14) of the guide (12).While maintaining the position of the wire delivery catheter (220)inside the right atrium (8), a clinician can extend the locating device(210) distally through the tricuspid valve (2) into the right ventricle(4) in a similar manner with respect to the wire delivery catheter (20)as described herein in accordance with FIGS. 2 a and 2 b. Similarly, thelocating device (210) can have a curved distal portion (212), eitherpreformed or actuated by a clinician, can be extended distally andretracted proximally, or be turned axially as indicated by thedouble-headed arrows in the FIG. 8 a.

Upon entering the right ventricle (4), the distal end (214) of thelocating device (210) is positioned at the first location (32) followingthe methods described herein in accordance with FIGS. 2 a-2 b, as wellas FIG. 7 a. Maintaining the position of the locating device (210)steady, the wire delivery catheter (220) is pushed distally toward thetricuspid annulus (3) so that the annulus (3) is sandwiched between thecatheter (220) and the locating device (210), as shown in FIG. 8 b. Awire (260 a) is advanced distally from the wire lumen (224) across thetricuspid annulus (3) and into the right ventricle (4), as shown in FIG.8 b. According to some embodiments, the distal end (214) of the locatingdevice (210) has openings or slots. In some embodiments, when the wire(260 a) advances across the tricuspid annulus (3), it enters theopenings or slots in the distal end (214) of the locating device (210).In other embodiments, the distal end (214) of the locating device (210)is configured that when a clinician retracts the locating device (210)proximally, he/she would not disturb the wire (260 a). According to someembodiments, the design and configuration of the wire (260 a) is similarto what is described herein according to FIGS. 4 a and 4 b. One skilledin the art would understand that the particular embodiments in FIGS. 8 aand 8 b only illustrate certain aspects of the present teachings andthat they should not be viewed as limiting the scope of the presentteachings.

According to some embodiments, upon placing the wire (160, 260) acrossthe first location (32) on the tricuspid annulus, the wire deliverycatheter (120, 220), the locating catheter (100), and/or the locatingdevice (210) are retracted proximally outside of the body. FIG. 9illustrates that the wire (160, 260) extends distally from a venousaccess site, tracks along the lumen of the wire delivery catheter (120,220), enters into the right atrium (8), crosses the tricuspid annulus(3), and reaches the right ventricle (4). The proximal end of the wire(160, 260) remains outside of the body and is controlled by a clinician.The distal end (162, 262) of the wire (160, 260) remains inside theright ventricle (4). In some embodiments, the wire (160, 260) has apiercing tip which allows it to perforate the tricuspid annulus (3) orhas a radio frequency energy delivery tip which delivers a radiofrequency energy to the annulus tissue to perforate the tricuspidannulus (3). Additionally, similar to what is described herein accordingto FIGS. 4 a and 4 b, the distal portion of the wire is designed todeflect or curl back to prevent inadvertent tissue damage, as shown inFIG. 9.

With the wire (60 a, 160 a, 260 a) in place across the tricuspid annulus(3), in various embodiments, a tissue anchor (310 a) is deployed at alocation. According to some embodiments, as illustrated in FIGS. 10-12,a first tissue anchor delivery catheter (300) is tracked along the wire(60 a, 160 a, 260 a), across the tricuspid annulus (3), and into theright ventricle (4). In certain embodiments, the tissue anchor deliverycatheter (300) is used to deliver a tissue anchor (310 a) to thetricuspid annulus (3).

While any tissue anchoring devices known in the art can be used, theparticular tissue anchor (310 a) in the present teachings, as shown inFIG. 10, is collapsible. In various embodiments, a tissue anchorcomprises a plurality of discrete, flat, or flexible anchor elements(312) coupled with a flexible tensile member (314). The anchor elements(312) can be made from a surgical grade fabric material (e.g., apolyester material such as DACRON), in some instances, designed topromote tissue in-growth so that the anchors (310 a) become at least inpart encased in tissue over-time. The anchor elements (312) are coupledto a tensile member (314), in this example, a suture, by threading thesuture distally through the anchor elements (312) and proximally throughthe anchor elements (312). A slip knot or another type of lockingmechanism is formed so that when a proximal end portion of the tensilemember (314) is pulled, all of the anchor elements (312) will be drawntogether. This leaves a long “tail” of the suture leading from theanchor to the venous access site and the long “tail” can be used forsubsequent tensioning and plication, as described herein.

Examples of a tissue anchor (310) and a tissue anchor delivery catheter(300) described in conjunction with the drawings of the presentteachings have some similarities to those in U.S. patent applicationSer. No. 12/273,670, filed on Nov. 19, 2008, entitled Tissue Anchor andAnchoring System, U.S. patent application Ser. No. 11/174,951, filed onJul. 5, 2005, entitled Tissue Anchor, Anchoring System and Methods ofUsing the Same, U.S. patent application Ser. No. 13/777,042, filed onFeb. 26, 2013, entitled Tissue Anchor and Anchoring System, each ofwhich is incorporated by reference herein in its entirety. Though notshown in the exemplary figures, other suitable tissue anchors can alsobe used. Examples of suitable tissue anchors include, but are notlimited to, tissue fasteners, tissue pledgets, or tissue staples etc.

FIGS. 11-12 illustrate an exemplary delivery and deployment of a firsttissue anchor (310 a) across the tricuspid annulus (3). FIGS. 11 a ad 12a illustrate the process of exposing of the distal portion (316 a) ofthe tissue anchor (310 a) and FIGS. 11 b and 12 b illustrate the processof exposing the proximal portion (318 a) of the tissue anchor (310 a),where the tissue anchor tracks along the wire (60 a, 160 a, 260 a) atthe location (32) according to the embodiments described in FIGS. 2-9.FIGS. 11 c and 12 c illustrate an exemplary deployment of the tissueanchor (310 a) positioned at the location (32) according to theembodiment described in association with FIGS. 2-9, where the tissueanchor tracks along the wire (60 a, 160 a, 260 a).

Referring to FIGS. 11 a and 12 a, a tissue anchor delivery catheter(300) holding a tissue anchor (310 a) inside its longitudinal lumen(302) tracks along the wire (60 a, 160 a, 260 a), across the tricuspidannulus (3), and into the right ventricle (4). Continuing to referringto FIGS. 11 a and 12 a, the tissue anchor (310 a) is partially pusheddistally outside of the distal end (304) of the tissue anchor deliverycatheter (300). Once the distal portion (316 a) of the tissue anchor(310 a) or a sufficient amount of the anchor elements (312, shown inFIG. 10) is exposed inside the right ventricle (4), a clinician stopspushing the tissue anchor (310 a) distally and retracts the tissueanchor delivery catheter (300) proximally so that the distal end (304)of the tissue anchor delivery catheter (300) moves proximally across theannulus (3) and back into the right atrium (8). The clinician thenexposes the proximal portion (318 a) of the tissue anchor (310 a) or theremainder of the anchor elements (312) of the tissue anchor (310 a)within the right ventricle (4) by further retracting the tissue anchordelivery catheter (300) proximally as shown in FIGS. 11 b and 12 b.

As illustrated in FIGS. 11 c and 12 c, to deploy the tissue anchor (310a), the clinician pulls the proximal end of the tensile member (314)such that the anchor elements (312) of the tissue anchor (310 a) aredrawn together against the opposite sides of the tricuspid annulus (3),thereby securing the first tissue anchor (310 a) to the tricuspidannulus (3). As a result, as illustrated in FIGS. 11 c and 12 c, thefirst tissue anchor (310 a) is deployed across the tricuspid annulus (3)at the first location (32) with the distal portion (316) of the tissueanchor (310 a) placed against the atrial side of the tricuspid annulus(3), the proximal portion (318) of the tissue anchor (310 a) placedagainst the ventricle side of the tricuspid annulus (3), and the tensilemember (314) of the first tissue anchor (310 a) extending proximallythrough the lumen (302) of the tissue anchor delivery catheter (300) tothe outside of the body. According to some embodiments, the wire (60 a,160 a, 260 a) that marks the first location (32) and maintains theannulus access during the deployment of the first tissue anchor (310 a)is then withdrawn proximally outside of the body, while the proximal endof the tensile member (314) is controlled by the clinician from outsideof the body.

Although exemplary embodiment herein disclosure proximal and distalportion (316 a) of the tissue anchors (310 a) are deployed/cinchedsimultaneously, one skilled in the art should understand that in analternative embodiment, distal portion (316 a) of the tissue anchors(310 a) can be deployed/cinched right after being exposed inside theright ventricle (4) and before the tissue anchor delivery catheter (300)being retracted back into the right atrium (8). Upon positioning thedeployed/cinched distal portion of the tissue anchor against the rightatrium side of the annulus (3), the proximal portion (318 a) is thenexposed within the right ventricle (4) and further deployed/cinchedagainst the tricuspid annulus (3). One skilled in the art shouldunderstand that specific examples disclosed herein should not be viewedas limiting. Similar tissue anchor deployment technique known in thefield could also be incorporated herein.

With the first tissue anchor (310 a) securely deployed at the firstlocation across the tricuspid annulus (3), the clinician can deploy asecond tissue anchor (310 b) at a second location (30) according to someembodiments of the present teachings. FIGS. 13-14 illustrate severalexemplary deployment of a second tissue anchor (310 b) at a secondlocation (30) across the tricuspid annulus (3).

According to some embodiments, similar to what is described in FIGS.2-6, a clinician uses the similar steps to position a wire deliverycatheter (20) against the tricuspid annulus (3) from inside the rightventricle (4) at the second location (30). According to someembodiments, the positioning of the wire delivery catheter against thetricuspid annulus includes extending, retracting, turning, or otherwisemanipulating the wire delivery catheter (20) to the second location (30)similar to the methods described herein or known to those with ordinaryskill in the art. Similar to what is described herein in accordance withthe FIGS. 2-6, one end of the second wire (60 b) is advanced across thetricuspid annulus (3), captured by the capture basket (44, 52) asillustrated in FIGS. 3 a and 3 b, and pulled proximally through thelumen (14) of the guide (12) outside of the body. As illustrated in FIG.13 a, it results in that the wire (60) is placed at the second location(30) and both the ends of the wire (60 b) are outside of the body.

According to alternative embodiments, similar to what is described inFIGS. 7-9, a clinician takes the similar steps to position the wiredelivery catheter (120, 220) against the tricuspid annulus (3) frominside the right atrium (8) at a second location (30). According to someembodiments, this is done by extending, retracting, turning, orotherwise manipulating a locating catheter (100) or a locating device(210) at the second location (30) through methods similar to thosedescribed herein or known to those with ordinary skill in the art.Similar to what is described in accordance with FIGS. 7-9, the wiredelivery catheter (120, 220) is positioned at the second location (30)through magnetic attraction or by the wire delivery catheter designdiscussed herein. As illustrated in FIG. 13 b, a second wire (160 b, 260b) is advanced distally across the tricuspid annulus (3) and reaches theright ventricle (4) as described herein. The result is illustrated inFIG. 13 b, where one end of the wire (160 b, 260 b) extends distallythrough the lumen (14) of the guide (12) and reaches the right ventricle(4). In other words, the distal end of the second wire (160 b, 260 b)resides inside the right ventricle (4) and the proximal end of thesecond wire (160 b, 260 b) resides outside of the body.

In various embodiments, a second tissue anchor (310 b) is deployed atthe second location (30) according to various embodiments describedherein in accordance with FIGS. 11-12. FIGS. 14 a and 14 b illustratethe embodiments where the second tissue anchor (310 b) is deployedacross the tricuspid annulus (3) at the second location (30) with thedistal portion (316 b) of the second tissue anchor (310 b) placedagainst the ventricle side of the annulus (3), the proximal portion (318b) of the tissue anchor (310 b) placed against the atrial side of theannulus (3), and the tensile member (314) of the second tissue anchor(310 b) extending proximally through the venous access to the outside ofthe body. At this point, the second wire (60 b, 160 b, 260 b) can beremoved.

FIG. 15 illustrates an exemplary bicuspidization of a tricuspid valve(2). According to some embodiments, a clinician applies tension to oneor both of the tensile members (314 a, 314 b) of the tissue anchors (310a, 310 b). This tension pulls two tissue anchors (310 a) closer to eachother, thereby reducing the circumference of the tricuspid annulus (3).This tension, and the reduced distance between the two tissue anchors(310 a, b), are maintained by directing a locker member (330) along thetensile members (314 a, 314 b) towards the tissue anchors (310 a, 310b). Suitable lockers include those well known in the art and thosedescribed in U.S. application Ser. No. 11/753,921, filed on May 25,2007, entitled Lockers for Surgical Tensile Members and Methods of Usingthe Same to Secure Surgical Tensile Members, the disclosure of which isincorporated herein by reference. With the tensile members (314 a, 314b) are secured by the locker (330), the excess tensile members (314 a,314 b) proximal to the locker (330) can be removed by a cutter, forexample, a cutter disclosed in U.S. patent application Ser. No.11/935,054, filed on Nov. 5, 2007, entitled Suture Cutter and Method ofCutting Suture, the disclosure of which is incorporated herein byreference. The guide (12) along with all the wire delivery catheters(20, 120, 220) and/or the tissue anchor delivery catheter (300) can thenbe retracted proximally and removed.

FIGS. 16 a and 16 b illustrate an exemplary process of bicuspidization.According to some embodiments, the first tissue anchor (310 a) isdeployed at a location at or close to the commissure of the posteriorand septal leaflets and the second tissue anchor (310 b) is deployed ata location at or close to the commissure of the posterior and anteriorleaflets, as illustrated in FIG. 16 a. Upon reducing the distancebetween the two tissue anchors (310 a, 310 b), the posterior annulus isshortened and the posterior leaflet is effectively eliminated, therebyturning the three-leaflet valve into a two-leaflet valve. In certaininstances, the process is called bicuspidization, as illustrated in FIG.16 b.

According to various embodiments of the present teachings, reducing thecircumference of the tricuspid annulus (3) facilitates a coaptation ofthe tricuspid valve (2) leaflets and reduces or eliminates the tricuspidregurgitation jet by at least one degree. According to some embodiments,both the tissue anchors (310 a, 310 b) are positioned along theposterior annulus. According to other embodiments, at least one tissueanchor (310 a) is positioned on the posterior annulus and the othertissue anchor (310 b) is placed on the anterior annulus or the septalannulus. According to yet other embodiments, at least one tissue anchor(310 a) is placed at a location at or close to the commissure of theposterior and septal leaflets and the other tissue anchor (310 b) isplaced at a location between the commissure of the posterior and septalleaflets and the commissure of the posterior and anterior leaflets.

According to some embodiments, two tissue anchors (310 a and 310 b) aredeployed around the annulus circumferences. According to otherembodiments, more than two tissue anchors (310 a, 310 b) are deployed.One exemplary embodiment as shown in FIGS. 16 c and 16 d, includes onetissue anchor (310 a) deployed at an location at or close to thecommissure of the posterior and septal leaflets, one tissue anchor (310b) deployed at an location at or close to the commissure of theposterior and anterior leaflets, and another tissue anchor (310 c)deployed approximately in the middle of the first two. One with ordinaryskill in the art would understand that although FIGS. 16 a-16 dillustrate certain embodiments of the present teachings, otherconfiguration and other locations can also be used for placing thetissue anchor (310 a). For example, four or more tissue anchors could beimplanted along the posterior annulus of the tricuspid valve. Thus, whatis described as to the locations of the tissue anchor (310 a) or thenumber of the tissue anchors (310 a) deployed should not be viewed aslimiting.

Additionally, although three tissue anchors are illustrated herein, morethan three tissue anchors can also be used without departing from thescope of the present teachings. According to some embodiments, tensionis applied to all tissue anchors and secured by one locker. According toother embodiments, tension is applied to two of the tissue anchors at atime, for example, as illustrated in FIGS. 16 e and 16 f

According to some embodiments, each tissue anchor is deployedsequentially. Specifically, the embodiments described in accordance withFIGS. 2-15 allow a clinician to place a wire (60, 160, 260) at the firstlocation (32), followed by deploying a first tissue anchor (310 a) overthe wire (60, 160, 260), and then manipulate the same wire deliverymechanism to and place the wire at a second location (30), followed bydeploying a second tissue anchor (310 b) over the wire (60, 160, 260).According other embodiments, two or more tissue anchors are deployedsimultaneously. Specifically, a multi-lumen translation catheter (400)can be used to place two wires at two locations at the same time.According to other embodiments, a catheter with more than two branchescan be used to place multiple wires at multiple locations at the sametime.

FIGS. 17-19 illustrate the use of a multi-lumen translation catheter(400) to place two wires (460 a, 460 b) across the tricuspid annulus(3). According to one embodiment, as illustrated in FIG. 17, amulti-lumen translation catheter (400) comprises a first catheter member(402 a) having a first lumen (404 a) for a first wire (460 a) and asecond catheter member (402 b) having a second lumen (404 b) for asecond wire (460 b). The first and second wires (460 a, 460 b) areslidably disposed within the first and second catheter lumens (404 a,404 b), respectively. There is a pre-defined lateral distance “L”between the first catheter member (402 a) and the second catheter member(402 b).

According to some embodiments, a multi-lumen translation catheter (400)is delivered to the right ventricle (4) and positioned against thetricuspid annulus (3) through a wire delivery catheter (20), asillustrated in FIG. 2 a. According to some embodiments, similar to whatis described herein in accordance with FIGS. 2-6, upon the wire deliverycatheter (20) being positioned against the tricuspid annulus (3) frominside the right ventricle (4), the first wire (460 a), extendingthrough the lumen (404 a) of the first catheter member (402 a), isplaced across the tricuspid annulus (3). The wire delivery catheter (20)is retracted proximally, exposing the second catheter member (402 b) ofthe multi-lumen translation catheter (400), as illustrated in FIG. 18 a.Once outside of the distal end (24) of the wire delivery catheter (20),the second catheter member (402 b) expands laterally away from the firstcatheter member (402 a) to a pre-defined distance. Without losing theplacement of the first wire (460 a), a clinician can turn themulti-lumen translation catheter (400) and/or the wire delivery catheter(20) so that the second catheter member (402 b) is positioned at asecond location (30). A second wire (460 b) is then advanced across thetricuspid annulus (3) following the steps described herein and shown inFIGS. 4 a and 4 b.

According to some embodiments, both the wires (460 a, 460 b) is capturedby the capture device and the distal ends of the both wires (460 a, 460b) are then withdrawn through the lumen (14) of the guide (12) outsideof the body. As a result, as illustrated in FIG. 18 b, two wires areplaced at two locations, which can be used to facilitate the deploymentof two tissue anchors (310 a), following the steps discussed above andin accordance with FIGS. 11 a-11 c.

According to other embodiments as illustrated in FIG. 19 a, amulti-lumen translation catheter or device (500) is delivered though thelumen of a locating catheter (100) to the right ventricle (4). As thedistal end (104) of the locating catheter (100) is positioned againstthe annulus (3), a first catheter member (502 a) is placed at a firstlocation (32), attracting a first wire delivery catheter (510 a) andfacilitating the placement of a first wire (560 a). The locatingcatheter (100) is retracted proximally, exposing a second cathetermember (502 b) of the multi-lumen translation catheter (500) asillustrated in FIG. 19 a. Once outside of the distal end (104) of thelocating catheter (100), the second catheter member (502 b) expandslaterally away from the first catheter member (502 a) to a pre-defineddistance. Without losing the placement of the first wire deliverycatheter (510 a), a clinician can turn the multi-lumen translationcatheter (500) and/or the locating catheter (100) so that the secondcatheter member (502 b) is positioned at a second location (30). Thesecond catheter member (502 b) attracts the second wire deliverycatheter (510 b) and facilitates the placement of the second wire (560b) across the tricuspid annulus (3) as shown in FIG. 19 b.

According to some embodiments, the multi-lumen translation catheter isplaced at two locations first and two wires are placed across thetricuspid annulus simultaneously or sequentially. Alternatively, inother embodiments, a first catheter member of a multi-lumen translationcatheter is positioned at a first location first and a first wire isplaced across the tricuspid annulus; a second catheter member of themulti-lumen translation catheter is positioned at a second location anda second wire is placed across the tricuspid annulus.

As a result, as illustrated in FIGS. 18 b and 19 b, two wires are placedat two locations, followed by the deployment of two tissue anchorsaccording to the steps or steps similar with those discussed herein andin accordance with FIGS. 11-16.

Although an exemplary multi-lumen translation catheter is describedabove, one with ordinary skill in the art would understand that a threeor more branched catheter can be used without departing from the spiritof the present teachings. The multi-lumen translation described inconjunction with the drawings of the present teachings have somesimilarities to those in U.S. patent application Ser. No. 11/685,239,filed on Mar. 13, 2007, entitled Systems and Methods for IntroducingElements Into Tissue; U.S. patent application Ser. No. 11/685,240, filedon Mar. 13, 2007, entitled Tissue Anchors, Systems, and Methods, andDevices; U.S. patent application Ser. No. 11/685,242, filed on Mar. 13,2007, entitled Devices and Methods For Introducing Elements into Tissue;and U.S. patent application Ser. No. 13/282,139, filed on Oct. 26, 2011,entitled Hand Operated Device for Controlled Deployment of a TissueAnchor and Method of Using the Same; each of which is incorporated inits entirety by reference herein.

Above described embodiment discloses the use of one locker membermaintaining tension on two or more tensile members. In alternativeembodiments of the present teaching, tricuspid annulus can be plicatedby a chain of tissue anchors. In some embodiments, two or more tissueanchors are connected together by a tensile member. Plication happens bypulling said tensile member and thereby drawing all tissue anchorstogether.

FIGS. 20A-C illustrates one embodiment of the present teaching where asingle tensile member may be used to deploy, fasten and draw together atleast two separate tissue anchors. As shown in FIG. 20A, first andsecond tissue anchors (610, 612) are deployed at spaced apart locationsalong the tricuspid valve annulus (3). Each tissue anchors (610, 612)includes an elongate strip (606 a, 606 b) of flexible material, such asfabric or other material as described above, as well as a single tensilemember (608) extending through each of the elongate strips (606 a, 606b). Upon deployment of the two tissue anchors (610, 612), the free end(614) of the tensile member (608) is pulled thereby securely fasteningthe first tissue anchor (610) as shown in FIG. 20A and subsequentlysecurely fastening the second tissue anchor (612) to the annulus (3)tissue as shown in FIG. 20B. Upon further tensioning of the tensilemember (608), the tissue anchors (610, 612) will be drawn together toplicate the tissue therebetween as shown in FIG. 20C. A locker member(616) may then be used to lock in the desired amount of plication bylock the free end (614) of the tensile member (608) as shown in FIG.20C. The free end (614) of the tensile member (608) may then be cut toappropriate length. One skilled in the art should understand that morethan two tissue anchors could be used with this teaching.

FIGS. 21A-21C illustrates another embodiment of the present teachingwhere tricuspid annulus is plicated by a chain of tissue anchors.Similar to above described methods, two tissue anchors (710,712) aresecured to tricuspid annulus (3), each with a tensile member (706, 708)extending proximally. FIG. 21A illustrates that the tensile members(706, 708) extend through a first locker member (702). Suitable lockermembers can include those described in U.S. patent application Ser. No.11/425,731 and U.S. patent application Ser. No. 11/753,921, thedisclosures of which are incorporated herein by reference, or othersuitable lockers known within the art. The first locker member (702) caninclude a locker body having a passageway through which the tensilemembers (706, 708) extend. A slidable member can be positioned withinthe passageway, which can be moved from a latent condition to anactivated condition to prevent the tensile members (706, 708) frommoving relative to the locker body. Both tensile members (706, 708) arepulled proximally by the clinician. Upon plicating annulus tissuebetween the first tissue anchor (710) and the second tissue anchor 712,the tensile members (706, 708) are locked by the first locker member(702) to preserve the plications created by tensioning as illustrated inFIG. 21B. According to some embodiments of the present teaching, asuture cutter is then advanced along tensile members (706, 708) to justproximal to the first locker member (702). In one embodiment, tensilemember (708) from the second tissue anchor (712) is cut while thetensile member (706) from the first tissue anchor (710) remains intact.In another embodiment, tensile member (706) from the second tissueanchor (710) is cut while the tensile member (708) from the first tissueanchor (712) remains intact.

According to some embodiments, to create a chain of plications, aclinician can then repeat method of tissue plication described above andextend the first tensile member (706) from the first tissue anchor (710)to a second locker member (704). As illustrated in FIG. 21B, a thirdtissue anchor (714) is further deployed across the posterior annulus (3)with a third tensile member (716) extending proximally. Upon plicatingannulus tissue between the first tissue anchor (710), and the thirdtissue anchor (714), the tensile members (706, 716) are locked by thesecond locker member (704) to preserve the plication created bytensioning as illustrated in FIG. 21C. The second locker member (704)can be the same as the first locker member (702), or if desired, adifferent suitable locker can be used. When tension is applied to thetensile members (706, 716), the tissue of the posterior annulus (3) isfurther plicated. This plication further reduces the size of thetricuspid valve orifice.

According to some embodiment, a suture cutter can then be advanced tocut the tensile members (706, 716) just proximal to the second lockermember (704). However, if plication is not complete such that theposterior, anterior and septal leaflets do not coapt, then additionaltissue anchors can be advanced to the annular tissue. Accordingly, atleast one of the tensile members (706, 716) remains intact to betensioned with a subsequently positioned tissue anchor.

According to various embodiments of the present teachings, a radioopaquemarker or textured surface can be used to make the device visible byusing radiographic imaging equipment such as an X-ray, magneticresonance, ultrasound or other imaging technique. A marker disclosedherein may be applied to any part of the guide, catheter, or devicesdisclosed in present teachings. A radioopaque marker can be sewed,adhered, swaged riveted, or otherwise placed and secured on the guide,catheter, and/or devices, The radioopaque marker may be made from amaterial selected from tantalum, tungsten, platinum, irridium, gold, analloy thereof, or another material known to those with ordinary skill inthe art. The radioopaque marker can also be made from cobalt, fluorione,or another paramagnetic material, or another MR visible material knownto those with ordinary skill in the arts. Additionally, a contrast mediainjected into the atrium, ventricle, or artery may also be used toconfirm the positioning under a fluoroscope.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this present teachings belong. Methods and materialssimilar or equivalent to those described herein can be used in thepractice or testing of the present teachings. In case of conflict, thespecification, including definitions, controls. In addition, thematerials, methods, and examples are illustrative only and not intendedto be limiting.

What is claimed is:
 1. A method for anchoring tissue within a heart of a patient comprising the steps of: locating a first tissue location inside a right ventricle; deploying a distal portion of a first tissue anchor at the first tissue location such that the distal portion is deployed into the right ventricle; deploying a proximal portion of the first tissue anchor at the first tissue location such that the proximal portion is deployed inside the right atrium; locating a second tissue location inside the right ventricle; deploying a distal portion of a second tissue anchor at the second tissue location such that the second anchor tissue is deployed into the right ventricle; deploying a proximal portion of the second tissue anchor at the second tissue location such that the proximal portion is deployed inside the right atrium; and plicating the tissue by changing the distance between the first and second tissue anchors.
 2. The method of claim 1, wherein at least one of the first and the second locations is on a tricuspid annulus of the heart.
 3. The method of claim 1, further comprising the step of advancing a wire from the right ventricle through the tricuspid annulus to the right atrium at the first location.
 4. The method of claim 3, further comprising the steps of capturing the wire within the right atrium and pulling the wire outside of a body of the patient, whereby the wire extends within the right ventricle and the right atrium.
 5. The method of claim 4, further comprising the step of advancing a tissue anchor catheter along the wire to the first location
 6. The method of claim 1, comprising the step of advancing a wire from the right atrium through a tricuspid annulus to the right ventricle at the first location, whereby the wire extends within both the right atrium and right ventricle.
 7. The method of claim 1, wherein the step of locating the second location occurs after the deployment of the first tissue anchor.
 8. The method of claim 1, wherein the step of locating the second location occurs prior to the deployment of the first tissue anchor.
 9. A method for repairing a tricuspid valve of a patient's heart comprising the steps of: positioning a wire delivery catheter through the tricuspid valve into a right ventricle with a distal end of the wire delivery catheter contacting a tricuspid annulus at a first location which is inside the right ventricle; advancing a wire through an axial lumen of the wire delivery catheter such that a first end of the wire passes from the right ventricle across the tricuspid annulus to a right atrium at the first location; capturing the first end of the wire with a capture device that is deployed inside the right atrium; retracting the capture device proximally away from the heart such that the first end of the wire extends outside of a body of the patient; and deploying a first tissue anchor at the first location using the wire as a guide, the first tissue anchor being deployed such that a distal portion of the first tissue anchor is positioned against the tricuspid annulus within the right ventricle, and a proximal portion of the first tissue anchor is positioned against the tricuspid annulus within the right atrium.
 10. The method of claim 9, further including the steps of: tracking a first tissue anchor delivery catheter over the wire, crossing the tricuspid annulus with a distal end of the first tissue anchor delivery catheter being disposed inside the right ventricle; deploying the first tissue anchor by passing the first tissue anchor though a lumen of the first tissue anchor delivery catheter; and retracting the end of the wire back into the axial lumen of the wire delivery catheter.
 11. The method of claim 9, further including the steps of: positioning the wire delivery catheter through the tricuspid valve into the right ventricle with the distal end of the wire delivery catheter contacting the tricuspid annulus at a second location which is inside the right ventricle, the second location being spaced from the first location; advancing a wire through an axial lumen of the wire delivery catheter such that the first end of the wire passes from the right ventricle across the tricuspid annulus to the right atrium at the second location; capturing the first end of the wire with the capture device that is deployed inside the right atrium; retracting the capture device proximally away from the heart such that the first end of the wire extends outside of a body of the patient; deploying a second tissue anchor at the second location using the wire as a guide, the second tissue anchor being deployed such that a distal portion of the second tissue anchor is positioned against the tricuspid annulus within the right ventricle, and a proximal portion of the second tissue anchor is positioned against the tricuspid annulus within the right atrium; and placating the tricuspid valve by reducing the distance between the first and second tissue anchors.
 12. The method of claim 9, wherein the capture device comprises a capture basket that moves between a radially deployed position and a retracted position, the basket being configured to receive and capture the first end of the wire.
 13. The method of claim 12, wherein the basket comprises a wire mesh formed of a memory shape material.
 14. The method of claim 9, wherein the tissue anchor comprises: a generally flexible anchor member capable of being inserted through tissue and moving between an elongate configuration and a shortened configuration suitable for anchoring against at least one side of the tissue, said anchor member having a proximal end portion, a distal end portion, and a compressible intermediate portion between said proximal end portion and said distal end portion, and a tensioning member extending through the proximal end portion to the distal end portion and back to an anchor point at the proximal end portion, the tensioning member being operatively connected to said anchor member such that said anchor member can slide relative to said tensioning member, said tensioning member capable of being pulled to cause said anchor member to move relative to said tensioning member from said elongate configuration to said shortened configuration wherein the compressible intermediate portion can compress and thereby adjust to the thickness of the tissue between the proximal and distal end portions.
 15. A method for repairing a tricuspid valve of a patient's heart comprising the steps of: positioning a locating catheter through the tricuspid valve into a right ventricle with a distal end of the locating catheter contacting the tricuspid annulus inside the right ventricle at a first location; advancing a wire delivery catheter into the right atrium with a distal end of the wire delivery catheter being disposed opposite the distal end of the locating catheter, and contacting the tricuspid annulus inside the right atrium at the first location; advancing a distal end of a wire from the right atrium across the tricuspid annulus to the right ventricle at the first location, wherein the wire tracks through an axial lumen of the wire delivery catheter; tracking a first tissue anchor delivery catheter over the wire, crossing the tricuspid annulus with a distal end of the first tissue anchor delivery catheter being disposed inside the right ventricle; and deploying a first tissue anchor through the first tissue anchor delivery catheter with a distal portion of the first tissue anchor positioned against the tricuspid annulus from inside the right ventricle, and a proximal portion of the tissue anchor being positioned against the tricuspid annulus from inside the right atrium.
 16. The method of claim 15, further including the steps of: retracting the distal end of the wire back into the axial lumen of the wire delivery catheter; positioning the locating catheter with the distal end of the locating catheter contacting the tricuspid annulus inside the right ventricle at a second location; positioning the wire delivery catheter into the right atrium with the distal end of the wire delivery catheter disposed opposite the distal end of the locating catheter and contacting the tricuspid annulus inside the right atrium at the second location; advancing the distal end of the wire from the right atrium across the tricuspid annulus to the right ventricle; tracking a second tissue anchor delivery catheter over the wire, crossing the tricuspid annulus at the second location with a distal end of the second tissue anchor delivery catheter inside the right ventricle; deploying a second tissue anchor with a distal portion of the second tissue anchor positioned against the tricuspid annulus from inside the right ventricle, and a proximal portion of the second tissue anchor positioned against the tricuspid annulus from inside the right atrium; and plicating the tricuspid annulus by reducing the distance between the first and second tissue anchors.
 17. The method of claim 15, wherein the distal end of each of the wire delivery catheter and the locating catheter includes a magnet for coupling the wire delivery catheter to the locating catheter, with the tricuspid annulus being disposed between the magnets.
 18. The method of claim 17, wherein each magnet is annular shaped and surrounds a lumen in the respective catheter, the wire passing between the opposing lumens of the respective catheters.
 19. The method of claim 16, wherein each of the first and second tissue anchor comprises: a generally flexible anchor member capable of being inserted through tissue and moving between an elongate configuration and a shortened configuration suitable for anchoring against at least one side of the tissue, said anchor member having a proximal end portion, a distal end portion, and a compressible intermediate portion between said proximal end portion and said distal end portion, and a tensioning member extending through the proximal end portion to the distal end portion and back to an anchor point at the proximal end portion, the tensioning member being operatively connected to said anchor member such that said anchor member can slide relative to said tensioning member, said tensioning member capable of being pulled to cause said anchor member to move relative to said tensioning member from said elongate configuration to said shortened configuration wherein the compressible intermediate portion can compress and thereby adjust to the thickness of the tissue between the proximal and distal end portions.
 20. A method for repairing a tricuspid valve of a patient's heart comprising: positioning a wire delivery catheter through a tricuspid valve into a right ventricle; slidably disposing a multi-lumen translation catheter within a lumen of the wire delivery catheter; slidably disposing a first wire within a first catheter member of the multi-lumen translation catheter; slidably disposing a second wire within a second catheter member of the multi-lumen translation catheter; positioning a distal end of the first catheter member at a first location; advancing a first end of the first wire from the right ventricle across the tricuspid annulus to a right atrium at the first location; expanding the second catheter member of the multi-lumen translation catheter and positioning a distal end of the second catheter member against the tricuspid annulus at a second location; advancing a first end of the second wire from the right ventricle across the tricuspid annulus to the right atrium at the second location; capturing the first ends of the first and second wires with a capture device; retracting the capture device proximally away from the heart and thereby extending the first ends of the first and second wires outside of the body; tracking a first tissue anchor delivery catheter over the first wire, a second tissue anchor delivery catheter over the second wire, crossing the tricuspid annulus with distal ends of the first and second tissue anchor delivery catheters inside the right ventricle; deploying the first and second tissue anchors such that distal portions of the first and second tissue anchors are positioned against the tricuspid annulus from inside the right ventricle, and proximal portions of the first and second tissue anchors are positioned against the tricuspid annulus from inside the right atrium; and plicating tissue of the tricuspid annulus by reducing the distance between the first and second tissue anchors.
 21. The method of claim 20, wherein each of the first and second tissue anchor comprises: a generally flexible anchor member capable of being inserted through tissue and moving between an elongate configuration and a shortened configuration suitable for anchoring against at least one side of the tissue, said anchor member having a proximal end portion, a distal end portion, and a compressible intermediate portion between said proximal end portion and said distal end portion, and a tensioning member extending through the proximal end portion to the distal end portion and back to an anchor point at the proximal end portion, the tensioning member being operatively connected to said anchor member such that said anchor member can slide relative to said tensioning member, said tensioning member capable of being pulled to cause said anchor member to move relative to said tensioning member from said elongate configuration to said shortened configuration wherein the compressible intermediate portion can compress and thereby adjust to the thickness of the tissue between the proximal and distal end portions.
 22. A method for repairing a tricuspid valve of a patient's heart comprising: positioning a locating catheter through a tricuspid valve into the right ventricle; slidably disposing a multi-lumen translation catheter within a lumen of the locating catheter, the multi-lumen translation catheter including a first catheter member and a second catheter member; positioning a distal end of the first catheter member at a first location; expanding the second catheter member of the multi-lumen translation catheter and positioning a distal end of the second catheter member against the tricuspid annulus at a second location; advancing first and second wire delivery catheters into the right atrium with distal ends of the first and second wire delivery catheters opposing the distal ends of the first and second catheter member, and contacting the tricuspid annulus inside the right atrium at the first and second locations; advancing distal ends of first and second wires the first and second wire delivery catheters, respectively, from the right atrium across the tricuspid annulus to the right ventricle at the first and second locations, respectively; tracking the first and second tissue anchor delivery catheters over the first and second wires, crossing the tricuspid annulus with distal ends of the first and second tissue anchor delivery catheters being disposed inside the right ventricle; deploying first and second tissue anchors with distal portions of the first and second tissue anchors being positioned against the tricuspid annulus from inside the right ventricle, and proximal portions of the first and second tissue anchors being positioned against the tricuspid annulus from inside the right atrium; and plicating tissue of the tricuspid annulus by reducing the distance between the first and second tissue anchors.
 23. The method of claim 22, wherein each of the first and second tissue anchor comprises: a generally flexible anchor member capable of being inserted through tissue and moving between an elongate configuration and a shortened configuration suitable for anchoring against at least one side of the tissue, said anchor member having a proximal end portion, a distal end portion, and a compressible intermediate portion between said proximal end portion and said distal end portion, and a tensioning member extending through the proximal end portion to the distal end portion and back to an anchor point at the proximal end portion, the tensioning member being operatively connected to said anchor member such that said anchor member can slide relative to said tensioning member, said tensioning member capable of being pulled to cause said anchor member to move relative to said tensioning member from said elongate configuration to said shortened configuration wherein the compressible intermediate portion can compress and thereby adjust to the thickness of the tissue between the proximal and distal end portions. 